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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
510(k) Number K964020
Device Name AXSYM CA 125
Applicant
Abbott Laboratories
Dept 49c, Bldg. Ap31
200 Abbott Rd.
Abbott Park,  IL  60064
Applicant Contact JOY C SONSALLA
Correspondent
Abbott Laboratories
Dept 49c, Bldg. Ap31
200 Abbott Rd.
Abbott Park,  IL  60064
Correspondent Contact JOY C SONSALLA
Regulation Number866.6010
Classification Product Code
LTK  
Date Received10/07/1996
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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